Core Viewpoint - InnoCare Pharma has initiated a registrational trial for mesutoclax, a BCL2 inhibitor, aimed at treating mantle cell lymphoma (MCL) patients previously treated with BTK inhibitors in China [1][3]. Group 1: Product and Mechanism - Mesutoclax is an orally bioavailable BCL2 selective inhibitor that targets the apoptosis pathway, which is crucial in the development of various hematologic malignancies [2]. - The drug has shown potential in treating multiple diseases, including MCL, chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), acute myeloid leukemia (AML), and myelodysplastic syndromes (MDS) [2]. Group 2: Clinical Development - The registrational trial is specifically designed to assess the safety and efficacy of mesutoclax in patients with BTKi-treated MCL, which is characterized as an aggressive form of B-cell non-Hodgkin lymphoma with limited treatment options [3]. - InnoCare is advancing clinical trials for mesutoclax across four indications both in China and globally [2]. Group 3: Company Overview - InnoCare is a commercial stage biopharmaceutical company focused on discovering, developing, and commercializing innovative drugs for cancer and autoimmune diseases with unmet medical needs [4]. - The company has established branches in major cities including Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States [4].

Core Insights - Nocera Healthcare reported a 74.3% year-on-year revenue growth in the first half of 2025, reaching 730 million yuan, driven by the strong performance of its core product, Oubatinib (brand name: Yinuokai®), and an upfront payment from a licensing agreement with Prolium [2][3] - The company's drug revenue increased by 53.5% year-on-year to 640 million yuan, primarily due to Oubatinib's inclusion in the national medical insurance, which has expanded its patient base, particularly in the marginal zone lymphoma indication [2] - Nocera's losses decreased by 86.7% year-on-year to 36 million yuan, attributed to increased operating income and improved cost efficiency [2] Financial Performance - Research and development expenses rose by 6.9% year-on-year to 450 million yuan, mainly for building a differentiated R&D platform and advancing more Phase III clinical projects [2] - As of June 30, 2025, the company held approximately 7.68 billion yuan in cash and cash equivalents, which will support the acceleration of multiple Phase III registration clinical trials and investments in differentiated ADC and other pipelines [2] Strategic Developments - 2025 marks the 10th anniversary of the company, which is entering a new phase of rapid development [3] - Significant progress has been made in advancing the product pipeline, achieving multiple key milestones that lay a solid foundation for long-term growth [3] - The company has formed strategic partnerships to expand its global footprint, including a licensing collaboration with Connoa and Prolium Bioscience to develop and commercialize the CD20×CD3 bispecific antibody ICP-B02 (CM355) [3] - Nocera continues to enhance its commercialization team's capabilities, leading to increased market penetration and revenue growth for Oubatinib, demonstrating the company's ability to translate scientific innovation into sustained business performance [3]

Group 1 - The company reported a revenue of 731 million yuan in the first half of 2025, a 74.76% increase compared to 420 million yuan in the same period last year [1] - Pharmaceutical sales revenue reached 641 million yuan, up 53.47% from 418 million yuan year-on-year [1] - The company achieved a net profit attributable to shareholders of -30 million yuan, narrowing the loss by 88.51% compared to -262 million yuan in the same period last year [1] Group 2 - The flagship product, Obinutuzumab, generated sales of 637 million yuan in the first half of 2025, reflecting a year-on-year growth of 52.84% [1] - The company received breakthrough therapy designation for ICP-248, which targets MCL (after BTK inhibitor treatment failure), with plans for clinical trials in four indications [1] - The first domestic CD19 monoclonal antibody, Tafasitamab, has been approved for use in combination with Lenalidomide for r/r DLBCL, with sales expected to start between late Q3 and early Q4 [1] Group 3 - Obinutuzumab's international phase III clinical trial for SPMS and PPMS has received FDA approval, with subject recruitment expected to begin in the second half of 2025 [2] - The company is exploring international collaboration potential for ICP-332 and ICP-488, two TYK2 inhibitors, across multiple indications [2] - Revenue projections for the company are estimated at 1.413 billion yuan, 1.787 billion yuan, and 2.385 billion yuan for 2025, 2026, and 2027 respectively [2]

| 证券代码：688428 | 证券简称：诺诚健华 | | | --- | --- | --- | | 港股代码：09969 | 港股简称：诺诚健华 | | | 上海荣正企业咨询服务（集团）股份有限公司 | | | | 关于 | | | | 诺诚健华医药有限公司 | | | | 之 | | | | 独立财务顾问报告 | | | | | | 目 录 | | 一、释义 | | | | 本公司、公司、上市公 InnoCare | Pharma | Limited，中文名称：诺诚健华医药有限公 | | 指 | | | | 司 司 | | | | 独立财务顾问 指 | 上海荣正企业咨询服务（集团）股份有限公司 | | | 上海荣正企业咨询服务（集团）股份有限公司关于诺诚健华 | | | | 独立财务顾问报告 指 医药有限公司 | 2024 | 年科创板限制性股票激励计划预留授予 | | 事项之独立财务顾问报告 | | | | 本激励计划、本计划 指 | 诺诚健华医药有限公司 2024 | 年科创板限制性股票激励计划 | | 限制性股票、第二类限 | | 符合本激励计划授予条件的激励对象，在满足相应归属条件 | | 指 ...

FANGDA PARTNERS http://www.fangdalaw.com 中国上海市石门一路 288 号 电子邮件 E-mail: email@fangdalaw.com 兴业太古汇香港兴业中心二座 24 楼 电 话 Tel.: +86-21- 2208 1166 邮政编码：200041 传 真 Fax.: +86-21-5298 5599 HKRI Taikoo Hui Shanghai, PRC 上海市方达律师事务所 关于诺诚健华医药有限公司（InnoCare Pharma Limited） 法律意见书 致：诺诚健华医药有限公司（InnoCare Pharma Limited） 上海市方达律师事务所（以下简称"本所"）是具有中华人民共和国境内法律 执业资格的律师事务所。根据诺诚健华医药有限公司（InnoCare Pharma Limited） （以下简称"诺诚健华"、"公司"或"上市公司"）的委托，本所担任诺诚健华 2024 年科创板限制性股票激励计划项目（以下简称"本激励计划"）的特聘专项法律顾 问，就本激励计划项下向激励对象授予预留限制性股票（以下简称"本次授予"或 "预留授予"）的有关事项出 ...

此次注册临床试验旨在评估Mesutoclax治疗既往BTK抑制剂经治的MCL患者的安全性和有效性。MCL是 一种侵袭性的B细胞非霍奇金淋巴瘤，目前疗法有限。 生物医药高科技公司诺诚健华(上交所代码：688428；香港联交所代码：09969)今天宣布，公司自主研 发的新型BCL2抑制剂mesutoclax(ICP-248)治疗BTK抑制剂经治的套细胞淋巴瘤(MCL)的注册临床试验完 成首例患者给药。 Mesutoclax是一款新型口服高选择性BCL2抑制剂，BCL2是细胞凋亡通路的重要调控蛋白，其表达异常 与多种恶性血液肿瘤的发生发展相关。Mesutoclax通过选择性地抑制BCL2，恢复肿瘤细胞程序性死亡 机制，从而发挥抗肿瘤疗效。这一独特的作用机制使其在治疗MCL、慢性淋巴细胞白血病/小淋巴细胞 淋巴瘤(CLL/SLL)、急性髓系白血病(AML)、骨髓增生异常综合征(MDS)等适应症中具有巨大的潜力， 诺诚健华正在中国和全球推进治疗MCL、CLL/SLL、AML和MDS等适应症的临床试验。 诺诚健华联合创始人、董事长兼CEO崔霁松博士说："Mesutoclax作为公司在血液瘤领域的重要资产， 有望为淋巴瘤患 ...

Investment Rating - The report maintains a "Buy" rating for the blood cancer drug industry [3][6]. Core Insights - The blood cancer market is expanding due to innovative therapies, with significant advancements in precision diagnosis, prognosis stratification, and targeted therapies such as CAR-T and TCE, leading to improved patient survival and quality of life [5][8]. - The number of patients with blood cancer who have survived for five years or more is approximately 4 million globally, which is three times the number of new patients, indicating a growing market for long-term treatments [5][13]. - The high cost of blood cancer drugs and the emergence of blockbuster products are driving market growth, with several drugs expected to exceed $10 billion in sales by 2024 [5][17]. Summary by Sections 1. Blood Cancer Market Expansion - The proportion of new blood cancer patients is less than 10% of all new cancer cases, with a steady increase in incidence rates [8]. - Blood cancer patients have a long survival period, resulting in a large population of existing patients [13]. - The high cost of blood cancer treatments contributes to the frequent emergence of blockbuster drugs [17]. 2. Clinical Diagnosis and Treatment of Blood Cancer - Blood cancers are classified based on cell origin, differentiation, and affected sites, including leukemia, lymphoma, and multiple myeloma [19][20]. - Treatment for acute leukemia primarily involves chemotherapy or targeted combination therapies to improve survival rates [24]. - Lymphoma treatment varies by subtype, with Rituximab being a cornerstone therapy [23]. - Multiple myeloma treatment focuses on CD38 monoclonal antibodies, with ongoing exploration of solutions for relapsed and refractory cases [23]. 3. Analysis of Popular Targets and Therapies - The BTK field is seeing intense competition, with new products emerging to address resistance issues [5]. - The BCL-2 area is advancing with differentiated designs and optimized dosing strategies [5]. - The BCR-ABL TKI domain is witnessing the introduction of third-generation inhibitors that show superior efficacy [5]. 4. Company Profiles - BeiGene is focusing on a comprehensive product matrix to cover CLL/SLL indications [5]. - Innovent Biologics is building a diversified product portfolio centered around Oubreti [5]. - Ascentage Pharma is developing third-generation BCR-ABL inhibitors and BCL-2 inhibitors to create competitive advantages [5]. - Diligent Pharma is innovating with a globally first high-selectivity JAK1 inhibitor and a dual-target LYN/BTK inhibitor [5]. 5. Investment Recommendations - The blood cancer sector presents numerous investment opportunities due to its complexity and the variety of treatment subfields [5]. - The long survival cycle of blood cancer patients and the high costs of drug treatments indicate a significant market potential [5].

登录新浪财经APP 搜索【信披】查看更多考评等级 A股代码：688428 A股简称：诺诚健华 公告编号：2025-034 港股代码：09969 港股简称：诺诚健华 诺诚健华医药有限公司 董事会决议公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性依法承担法律责任。 一、董事会会议召开情况 诺诚健华医药有限公司（以下简称"诺诚健华"或"公司"）于2025年8月20日在公司会议室以现场会议结 合通讯方式召开董事会。会议应出席董事7人，实际出席董事7人，董事会主席Jisong Cui（崔霁松）博 士担任会议主席。会议的召集、召开、表决程序符合有关法律、行政法规、部门规章、规范性文件和公 司章程的规定。 二、董事会会议审议情况 （一）审议通过《根据2024年科创板限制性股票激励计划向激励对象授予预留限制性股票》的议案 根据《上市公司股权激励管理办法》《2024年科创板限制性股票激励计划（草案）》及其摘要的相关规 定和公司2024年第一次临时股东大会（股东特别大会）的审议批准及授权，董事会认为公司2024年科创 板限制性股票激励计划规定的预留授予条 ...

Core Viewpoint - Nocera Biopharma (688428) reported a significant increase in revenue and a reduction in net loss for the first half of 2025, indicating improved operational performance and profitability metrics [1]. Financial Performance - Total revenue for the first half of 2025 reached 731 million yuan, a year-on-year increase of 74.26% compared to 420 million yuan in the same period of 2024 [1]. - The net loss attributable to shareholders was 30.09 million yuan, which is an improvement of 88.51% from a loss of 26.2 million yuan in the previous year [1]. - The gross margin increased to 89.51%, up 4.48% year-on-year, while the net margin improved to -4.87%, a significant increase of 92.37% [1]. - Total expenses (selling, administrative, and financial) amounted to 282 million yuan, accounting for 38.5% of revenue, a decrease of 15.49% year-on-year [1]. Cash Flow and Assets - Operating cash flow per share improved to -0.04 yuan, an increase of 78.12% year-on-year [1]. - The company’s cash and cash equivalents showed a slight increase of 0.47% to 6.981 billion yuan [3]. - Accounts receivable rose by 39.76% to 392 million yuan, attributed to increased sales of the drug Aobutini [3]. Investment and R&D - The company is focusing on strategic collaborations, including a partnership with West Lake University for innovative drug development [19]. - Nocera Biopharma is integrating AI technology into drug discovery and clinical development processes to enhance operational efficiency [19][20]. Market Position and Fund Holdings - The largest fund holding Nocera Biopharma shares is the Fortune Precision Medical Mixed A fund, which holds 12.58 million shares [18]. - The company has seen a mixed response from funds, with some increasing their holdings while others have reduced their positions [18].

诺诚健华(09969)发布公告，于2025年8月20日，公司根据2023年股权激励计划授予三名承授人21万份受 限制股份单位，相当于公司于本公告日期已发行股份总数的约0.01%。 ...